randomized trial of dermatome technique vs. linear incision without soft tissue reduction: clinical...
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Randomized Trial of Dermatome Technique vs. Linear Incision without Soft Tissue Reduction:
Clinical measures and patient reported outcome
Morten Høgsbro, M.D., M.Sc.Andreas Agger, M.D.
Lars Vendelbo Johansen, M.D., D.MSc.Aarhus University Hospital
October 9th 2014
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Background• Trend towards less invasive Bone Anchored
Hearing Implant (BAHI) surgery
• Promising results with linear incision without soft tissue reductiono Hultcrantz M. Outcome of the bone-anchored hearing aid procedure without skin
thinning: a prospective clinical trial. Otol Neurotol. 2011;32(7):1134–1139.
• It is unknown whether patient reported outcome differs for different operative techniques
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Objective• Investigation of differences between
• The linear incision with no soft tissue reduction and
• The dermatome technique related to:o Primary soft tissue healing o Long term soft tissue related issues o Patient reported outcome
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Study design• (Part of a) randomized, controlled study (n=47)
• Linear incision without subcutaneous reduction (n=25)
• Dermatome technique (n=22)
• Loading time: two weeks
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Results
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Baseline characteristics
Baseline characteristics Surgical technique
Linear incision Dermatome technique Mean Standard deviation Count % Mean Standard deviation Count %
Age at operation 61.44 11.61 60.23 13.46
Sex Male 11 44.0 15 68.2 Female 14 56.0 7 31.8
Indication for BAHI Conductive hearing loss 6 24.0 5 22.7 Mixed hearing loss 16 64.0 12 54.5 Single sided deafness 3 12.0 5 22.7
Smoking No 22 88.0 17 77.3 Yes 3 12.0 5 22.7
Surgeon Surgeon 1 (LVJ) 12 48.0 10 45.5 Surgeon 2 (AA) 13 52.0 12 54.5
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Time to processor loading
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Dermatome 90 days
Dermatome 180 days Linear 90
daysLinear 90 days
Linear 180 days
Linear 180 days
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Holgers index
Holgers score
Visit (days) 3 7 10 14 21 30 90 180 365 Total
Group (Linear incision / Dermatome) Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der
Total number analyzed 25 22 25 22 25 22 24 22 24 21 25 22 25 22 23 22 23 22 219 197
Holger’s grade % % % % % % % % % % % % % % % % % % % %
Grade 0 (No irritation) 88.0 77.3 92.0 54.5 84.0 54.5 100.0 77.3 91.7 66.7 80.0 77.3 84.0 95.5 87.0 86.4 100.0 90.9 89,5 75,6
Grade 1 (Slight redness) 12.0 13.6 8.0 31.8 12.0 40.9 0 9.1 8.3 23.8 20.0 22.7 8.0 4.5 13.0 13.6 0 9.1 9,1 18,8 Grade 2 (Red and slightly moist tissue) 0 9.1 0 13.6 4.0 4.5 0 9.1 0 4.8 0 0 4.0 0 0 0 0 0 0,9 4,6
Grade 3 (Reddish and moist) 0 0 0 0 0 0 0 4.5 0 4.8 0 0 0 0 0 0 0 0 0,0 1,0 Grade 4 (Infection requiring removal of abutment or implant) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0,0 0,0
R (Removal of implant not related To skin problems) 0 0 0 0 0 0 0 0 0 0 0 0 4.0 0 0 0 0 0 0,5 0,0
p-value (Wilcoxon W) 0.289 0.003 0.037 0.015 0.034 0.822 0.195 0.954 0.144 0,00014
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Pain
Pain score Visit (days) 3 7 10 14 21 30 90 180 365 Total
Group (Linear incision / Dermatome) Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der
Total number analyzed 25 22 25 22 25 22 24 22 24 21 25 22 25 22 23 22 23 22 219 197
Pain score % % % % % % % % % % % % % % % % % % % %
None 96.0 81.8 96.0 59.1 92.0 63.6 83.3 81.8 87.5 95.2 88.0 90.9 96.0 95.5 82.6 81.8 100.0 86.4 91,3 81,7
Limited 4.0 9.1 4.0 31.8 8.0 31.8 16.7 13.6 12.5 4.8 12.0 9.1 4.0 4.5 13.0 18.2 0 13.6 8,2 15,2
Moderate 0 4.5 0 4.5 0 4.5 0 4.5 0 0 0 0 0 0 4.3 0 0 0 0,5 2,0
Extensive 0 4.5 0 4.5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0,0 1,0
p-value (Wilcoxon W) 0.111 0.002 0.018 0.841 0.368 0.749 0.927 1.000 0.070 0.003
Months after surgery Months after surgery
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Numbness
Sensibility loss score Visit (days) 3 7 10 14 21 30 90 180 365 Total
Group (Linear incision / Dermatome) Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der Lin Der
Total number analyzed 25 22 25 22 25 22 24 22 24 21 25 22 25 22 23 22 23 22 219 197
Numbness score: % % % % % % % % % % % % % % % % % % % %
None 88.0 68.2 96.0 50.0 100.0 45.5 100.0 45.5 91.3 55.0 96.0 54.5 92.0 22.7 91.3 31.8 95.7 31.8 94.5 44.9
Limited 12.0 18.2 4.0 27.3 0 31.8 0 36.4 8.7 40.0 4.0 31.8 8.0 68.2 8.7 40.9 4.3 50.0 5.5 38.3
Moderate 0 13.6 0 22.7 0 22.7 0 18.2 0 5.0 0 13.6 0 9.1 0 22.7 0 13.6 0 15.8
Extensive 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4.5 0 4.5 0 1.0
p-value (Wilcoxon W) 0.078 .000 .000 .000 0.007 0.001 .000 .000 .000 <10-6
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Glasgow Benefit Inventory
Surgical intervention Total
Linear incision Dermatome
Subdomain
Mean(S.E.)
Mean(S.E.)
Mean difference (95% Confidence Interval)
Mean (95% confidence interval)
General domain 30.11 (6.46) 30.16 (7.64) -0.05 (-20.2 - 20.1) 30.14 (20.2 – 40.1)
Social support 9.85 (3.74) 8.73 (5.09) 1.11 (-11.6 – 13.8) 9.30 (3.0 – 15.6 )
Physical health 3.79 (3.46) -1.59 (2.27) 5.38 (-3.1 – 13.8) 1.16 (-3.1 – 15.4)
Total score 22.35 (4.53) 21.30 (5.18) 1.05 (-12.8 – 14.9) 21.83 (15.0 – 28.7)
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Conclusions• The linear incision technique is superior regarding
the healing time and the postoperative complications soft tissue reaction, pain and sensibility loss.
• Most issues with soft tissue reactions and pain were isolated to the early post-operative period while issues with sensibility loss subsided throughout the one year follow-up period.
• The linear incision with no subcutaneous reduction is a minimally invasive, fast and safe procedure with only a small risk of complications.
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Acknowledgements
• Dept. of Otorhinolaryngology, Head and Neck surgery, Aarhus University hospital
• Stina Wigren, Cochlear Bone Anchored Solutions